Labeling Compliance Manager

An employer is seeking a Labeling Compliance Manager for a contract opportunity in the Cincinnati, OH or Danvers, MA area. This Labeling Consultant's primary responsibility will be to run point on CAPAs for labeling compliance, IFUs and unique devices for the labeling center of excellence team. This Project Manager will be required to work cross functionally with all stakeholders within the regulatory business segment and must be comfortable presenting at a high level. The goal of this project is to ensure translations are correct for the active IFUs in investigation and prepare for labeling updates come Q4. In order to be successful at this role the resource must have product labeling experience within the medical device field, managing CAPAs cradle to grave, prior EU MDR knowledge, root cause analysis background and advance excel skills to complete the day-to-day requirements. The bulk of this role can be completed in Cincinnati or Danvers, but 2-3 times a quarter travel to Danvers will be required if not located there. This role will be hybrid on site and remote and can ultimately lead to full time employment with the end customer.

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4+ years of medical device product labeling background
SAP, ETQ or another end labeling system background
EU MDR knowledge
Advanced excel skills
Managing CAPA and IFUs from cradle to grave

J&J Experience

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.